Drug Helps Tackle Type 2 Diabetes in New Way, Study Says

But results suggest that dapagliflozin would be an 'add-on' rather than a replacement for regular therapy

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THURSDAY, June 24, 2010 (HealthDay News) -- A new drug, the first in its class, gives added blood sugar control to people with type 2 diabetes who are already taking the glucose-lowering medication metformin.

The new agent, dapagliflozin, which also helped patients lose weight, is novel in that it does not work directly on the body's insulin mechanisms, according to a study appearing in the June 26 issue of The Lancet and slated for presentation at the annual meeting of the American Diabetes Association (ADA) in Orlando, Fla.

"It will probably be used as an add-on therapy," said study author Clifford Bailey, a chemical pathologist and professor of clinical science at Aston University in Birmingham, U.K. "If you don't quite get to target with [the first therapy tried], this approach would offer you an opportunity hopefully to maintain improved control."

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Bailey, who could not predict if or when the drug might get final approval from drug regulatory authorities, also pointed out that dapagliflozin is flexible, meaning it can be used with various other treatments and at more or less any stage in the disease.

"It's a good add-on," agreed Dr. Stanley Mirsky, an endocrinologist at Lenox Hill Hospital, and associate clinical professor of metabolic diseases at Mount Sinai Medical Center, New York City. "Is it a wonder drug? No. It may play a small role.

"This could be used at any time during the continuum of diabetes, whether beginning, middle or towards the end of the lifespan of the patient," said Dr. Anupa Patel, senior clinical fellow in endocrinology at the Texas A&M Health Science Center College of Medicine and at Scott & White in Temple. "It could be added on at any time as an adjunct to therapy, [but] there should be some other type of therapy whether insulin or an oral agent."

Patel noted that there were statistically significant improvements in weight loss and blood sugar levels over time, especially at the two higher doses. Even at the end of one week, she said, "there was a significant decline in fasting plasma glucose in the two higher doses."

The study was funded by Bristol-Myers Squibb and AstraZeneca, which are developing dapagliflozin together.

Dapagliflozin works by stimulating the kidneys to eliminate more glucose from the body via urine.

In this study of 534 adult patients with type 2 diabetes who were already taking metformin, the highest dose of dapagliflozin (10 milligrams [mg] daily) was associated with a 0.84 percent decrease in HbA1c levels.

In the placebo group, the decrease in HbA1c was 0.3 percent, the study found.

Weight loss was also greater in volunteers taking the study drug: 2.2 kilograms (4.8 pounds) in the 2.5-mg group; 3 kilograms (6.6 pounds) in the 5-mg group; and 2.9 kilograms (6.4 pounds) in the 10-mg group.

Those in the placebo group lost 0.9 kilograms, or almost 2 pounds.

Much, though not all, of this loss was likely water weight, the authors stated.

There were more genital infections seen among those taking dapagliflozin, the team noted.

"One of the complications of the drug is an increase in urinary tract infections or yeast infections because you have high glucose levels in the urine," said Dr. Jacob Warman, chief of endocrinology at The Brooklyn Hospital Center in New York City. "That's a very good culture medium for yeast, so the endocrinologists aren't too happy about that."

On the other hand, he said, this drug appears to work without some of the kidney, liver and muscle complications of other drugs so "it would be excellent as an add-on to usual medications."

A second study, also simultaneously being presented at the ADA meeting and published in The Lancet, found that adding inhaled insulin before each meal and long-acting insulin glargine before going to bed worked just as well as conventional therapy.

The regular therapy consisted of taking biaspart insulin twice a day. This is a combination of short-acting insulin and intermediate-acting insulin.

The new regimen involved less weight gain, fewer episodes of low blood sugar and was more convenient, according to the study, which was funded by MannKind, the maker of Technosphere, the inhaled insulin featured in the trial.

A third study found that once-weekly injections of the drug exenatide (Byetta) worked better at controlling blood sugar levels than long-acting insulin.

The practice thus far has been to give Byetta twice a day. This study, funded by Amylin Pharmaceueticals and Eli Lilly, looked at a new formulation of the drug.

Patients who got the once-a-week form also lost an average of 2.6 kilograms (5.7 pounds), the study found.